Do nut and seed facilities need a preventive controls plan?

Generally yes. Under 21 CFR Part 117, the facility does a hazard analysis, and for nuts and seeds that analysis typically flags three hazards: aflatoxin, Salmonella, and allergen cross-contact. Where a hazard requires a control, the plan documents it. Some small or qualified facilities have modified requirements.

What are the most common reasons nut shipments get held?

Undeclared or incorrectly declared allergens, aflatoxin above the action level, Salmonella findings, and importing from an unregistered facility. Getting allergen labeling and contamination controls right up front is what keeps products moving at the port.

Nuts & Seeds · FDA

Last updated: July 2026

FDA Registration for Nuts & Seeds

Q: Do nuts and seeds need FDA registration?

The facility that processes, packs, or holds nuts and seeds registers with FDA, and foreign facilities need a U.S. Agent. Nuts and seeds are conventional food, but FDA watches them closely for two reasons — they're major allergens and they're prone to aflatoxin and Salmonella. Registration identifies the facility; it isn't product approval.

Q: Why does FDA scrutinize nuts and seeds so much?

Two reasons dominate. First, allergens: tree nuts and peanuts are major allergens, and sesame — a seed — became the ninth major allergen. Second, contamination: nuts are prone to aflatoxin (a mold toxin) and, as low-moisture foods, to Salmonella. Both are frequent causes of detention and refusal at import.

Q: What is aflatoxin and what's the limit?

Aflatoxin is a toxin produced by Aspergillus molds that can occur in peanuts and tree nuts. FDA's action level for total aflatoxins in human food such as nuts is 20 parts per billion — above that, the product can be considered adulterated under Section 402(a)(1) of the FD&C Act. Aflatoxin is one of the most common reasons nut shipments are refused at the border.

Q: How is Salmonella controlled in nuts?

Nuts and seeds are low-moisture foods, and Salmonella can survive in them for a long time — several outbreaks have been linked to nuts and nut butters. Control usually means a validated kill step (such as roasting, steam, or other pasteurization) plus sanitation and testing, addressed in the facility's preventive-controls plan.

Q: How do I label tree nuts?

Tree nuts must be declared by their specific type — almond, walnut, pecan, cashew, and so on — not just 'tree nuts.' In its 2025 allergen guidance, FDA narrowed the list of tree nuts requiring allergen labeling to twelve types and removed some, including coconut, from the major tree-nut list. Declaring the specific nut is the key labeling discipline.

Q: Is sesame an allergen now?

Yes. Under the FASTER Act, sesame became the ninth major food allergen, with the labeling requirement effective January 1, 2023. Because sesame is a seed, it's directly relevant here — sesame seeds, tahini, and products containing them must declare sesame as a major allergen.

Q: Are peanuts tree nuts?

No — peanuts are legumes, not tree nuts, but they are their own major allergen and must be declared. People allergic to peanuts aren't necessarily allergic to tree nuts and vice versa, which is exactly why FDA requires each to be labeled specifically.

Q: Do importers need FSVP and prior notice?

Yes. Imported nuts and seeds need a registered foreign facility with a U.S. Agent, prior notice for each shipment, and an importer FSVP verifying the supplier. Given aflatoxin and Salmonella risks, supplier verification and testing are central to a defensible FSVP for these products.

Nuts and seeds are conventional food to FDA — the facility registers, the label must comply, and preventive controls apply. But two things put them under a brighter spotlight than most foods: they're major allergens (tree nuts, peanuts, and sesame — a seed) and they're prone to aflatoxin and Salmonella. Get the allergen declaration and the contamination controls right and you've handled what actually gets nut shipments detained. Registration ≠ approval.

Almonds, peanuts, cashews, pistachios, sunflower, chia, sesame — same two questions decide compliance: is it labeled right, and is it safe?

Get Nut-Compliant The Two Hazards

Key Takeaways

Nuts & seeds are conventional food — registration, labeling, preventive controls.
Aflatoxin action level: 20 ppb total aflatoxins — a top import-refusal cause.
Salmonella survives in low-moisture nuts — needs a validated kill step.
Tree nuts declared by type; FDA's 2025 guidance narrowed the list to 12 (coconut removed).
Sesame is the 9th allergen (a seed) — effective Jan 1, 2023.
Part 117 hazard analysis for nuts flags aflatoxin, Salmonella, and allergen cross-contact.

Where they sit — and why the spotlight. A bag of almonds is a conventional food, so it follows facility registration, food labeling, and preventive controls like any packaged food. What makes nuts and seeds different isn't the framework — it's the risk profile. They sit at the intersection of the two issues FDA cares about most at the border: allergen labeling and contamination.

The Two Hazards

Aflatoxin and Salmonella

20 ppb

The aflatoxin action level. Total aflatoxins above 20 parts per billion can render nuts adulterated under Section 402(a)(1). Aflatoxin comes from Aspergillus molds in peanuts and tree nuts, and it's one of the most common reasons nut shipments are refused at import.

Aflatoxin (a mold toxin)

Managed through supplier controls, sorting out moldy/defective nuts, and testing to stay within the action level. Peanuts, pistachios, and Brazil nuts get particular attention, and imports are routinely sampled.

Salmonella (a pathogen)

Nuts are low-moisture foods where Salmonella can persist — several outbreaks trace to nuts and nut butters. Control means a validated kill step (roasting, steam, or other pasteurization) plus sanitation and testing.

Both are handled in the facility's preventive-controls plan (below). For imports, they're also the heart of a defensible FSVP — supplier verification and testing.

The Other Half

Allergen Labeling — Declare by Type

Nuts and seeds are central to the major-allergen rules, so labeling has to be precise:

Tree nuts

Declare the specific type (almond, walnut, cashew…). FDA's 2025 guidance narrowed the labeling list to 12 tree nuts and removed some, including coconut.

Peanuts

A separate major allergen — peanuts are legumes, not tree nuts. A peanut allergy isn't a tree-nut allergy, which is why each is labeled on its own.

Sesame

The 9th major allergen (effective Jan 1, 2023). A seed — so sesame, tahini, and products with them must declare it.

On shared equipment, allergen cross-contact is its own hazard — a peanut line running cashews, for instance. See allergen labeling requirements for the full rules on declaration and cross-contact.

Preventive Controls

The Hazard Analysis for Nuts & Seeds

Hazard	Typical control	Framework
Aflatoxin	Supplier controls, sorting, testing (≤ 20 ppb)	21 CFR Part 117
Salmonella	Validated kill step + sanitation + testing	21 CFR Part 117
Allergen cross-contact	Segregation, scheduling, cleaning, label controls	21 CFR Part 117

Under the preventive controls rule, the facility runs a hazard analysis; for nuts and seeds it almost always lands on these three. Where a hazard needs a control, the plan documents it. Some small or qualified facilities have modified requirements — see our FSMA overview.

Step by Step

Bringing a Nut or Seed Product to Market

Register the facility

The processor/packer/holder registers; foreign facilities add a U.S. Agent.

Run the hazard analysis

Part 117: evaluate aflatoxin, Salmonella, and allergen cross-contact.

Control contamination

Aflatoxin testing/supplier controls (≤ 20 ppb) and a validated Salmonella kill step.

Get allergen labeling right

Declare tree nuts by type, plus peanuts and sesame; control cross-contact.

Handle imports

Registration, U.S. Agent, FSVP, and prior notice before shipping.

Keep it current

Renew every two years; keep testing and food-safety records; revisit labels on change.

Labeled Right, Tested Safe

Get Your Nuts & Seeds to Market

FDA Registration Assistance registers nut and seed facilities, serves as U.S. Agent, reviews allergen labeling, supports preventive-controls hazard analysis for aflatoxin and Salmonella, and handles FSVP and prior notice — so labeling and contamination issues surface before the port, not at it.

Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Trusted by companies across 135+ countries, with 15+ years of experience.

Get Started Allergen Labeling

FAQ

Frequently Asked Questions

1. Do nuts and seeds need FDA registration?

The facility that processes, packs, or holds them registers, and foreign facilities need a U.S. Agent. Nuts and seeds are conventional food, but FDA watches them closely for allergens and for aflatoxin/Salmonella. Registration isn't approval.

2. Why does FDA scrutinize nuts and seeds so much?

Two reasons: allergens (tree nuts and peanuts are major allergens; sesame — a seed — is the 9th) and contamination (aflatoxin, plus Salmonella in these low-moisture foods). Both are frequent causes of detention and refusal at import.

3. What is aflatoxin and what's the limit?

A toxin from Aspergillus molds that can occur in peanuts and tree nuts. FDA's action level for total aflatoxins in human food like nuts is 20 parts per billion — above that, the product can be adulterated under Section 402(a)(1). It's a top reason nut shipments get refused.

4. How is Salmonella controlled in nuts?

Nuts are low-moisture foods where Salmonella can persist — outbreaks have been linked to nuts and nut butters. Control usually means a validated kill step (roasting, steam, other pasteurization) plus sanitation and testing, documented in the preventive-controls plan.

5. How do I label tree nuts?

By specific type — almond, walnut, pecan, cashew — not just "tree nuts." FDA's 2025 allergen guidance narrowed the labeling list to twelve tree nuts and removed some, including coconut, from the major tree-nut list.

6. Is sesame an allergen now?

Yes — under the FASTER Act, sesame became the 9th major food allergen, effective January 1, 2023. As a seed, it's directly relevant: sesame seeds, tahini, and products containing them must declare sesame.

7. Are peanuts tree nuts?

No — peanuts are legumes, but they're their own major allergen and must be declared. A peanut allergy isn't necessarily a tree-nut allergy, which is why FDA requires each to be labeled specifically.

8. Do nut facilities need a preventive controls plan?

Generally yes — under 21 CFR Part 117, the hazard analysis for nuts and seeds typically flags aflatoxin, Salmonella, and allergen cross-contact. Where a hazard needs a control, the plan documents it. Some small/qualified facilities have modified requirements.

9. What about raw nuts straight from a farm?

Raw agricultural commodities can involve different requirements, and some farm activities fall under other rules. But once nuts are roasted, shelled, ground, flavored, or packaged for sale, a facility is generally involved and registers. Classification depends on the operation.

10. Do importers need FSVP and prior notice?

Yes — imported nuts need a registered foreign facility with a U.S. Agent, prior notice per shipment, and an importer FSVP. Given aflatoxin and Salmonella, supplier verification and testing are central.

11. Is "FDA registered" the same as "FDA approved"?

No — registration tells FDA a facility exists and what it does; it isn't approval of the product. "FDA approved" based on registration is inaccurate.

12. Why do nut shipments get held?

Undeclared or wrong allergens, aflatoxin above the action level, Salmonella findings, and unregistered facilities. Getting allergen labeling and contamination controls right up front keeps products moving.

13. Is compliance a one-time task?

No — registration renews every two years, testing and food-safety records stay current, and each import needs prior notice. New products or reformulations mean revisiting labels and allergen controls.

14. How does FDA Registration Assistance help?

It registers nut and seed facilities, serves as U.S. Agent, reviews allergen labeling, supports hazard analysis for aflatoxin and Salmonella, and handles FSVP and prior notice, for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.

Reviewed By Hector Matos, Senior Regulatory Compliance Specialist · 15+ years FDA compliance experience · Updated July 2026